BEUDAMED
    FDA Adverse Event Death Summary report: N

    SINGLE USE 3-LUMEN EXTRACTION BALLOON V

    MDR report key: 16025331 · Received December 21, 2022

    Report

    Report Number
    9614641-2022-00822
    Event Type
    Death
    Date Received
    December 21, 2022
    Date of Event
    July 20, 2022
    Report Date
    February 10, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED "3-LUMEN BALLOON-V", OLYMPUS SELECTED "B-V232P-A" WHICH WAS SHIPPED THE MOST IN THE STUDY PERIOD. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE DOI.ORG/10.1016/J.GIE.2022.07.018 PROVIDED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE AUTHOR AND TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL / LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "EUS-GUIDED GASTROENTEROSTOMY VERSUS DUODENAL SELF-EXPANDABLE METAL STENT FOR MALIGNANT GASTRIC OUTLET OBSTRUCTION: RESULTS FROM A NATIONWIDE MULTICENTER RETROSPECTIVE STUDY (WITH VIDEO)." THIS MULTICENTER, OBSERVATIONAL STUDY OF D-SEMS AND EUS-GE PROCEDURES FOR PATIENTS WITH MALIGNANT GOO WAS CONDUCTED IN 97 PATIENTS. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES REGARDING TECHNICAL (92.8% VS 93.7%) OR CLINICAL SUCCESS (83.5% VS 92.4%) WERE FOUND. PATIENTS IN THE EUSGE GROUP HAD IMPROVED STENT PATENCY WHEN COMPARED WITH THOSE PATIENTS IN THE DUODENAL SELF-EXPANDABLE METAL STENT (D-SEMS) GROUP AT 3 MONTHS (92.23% VS 80.6%; ADJUSTED HAZARD RATIO, .37; P Z .033). THIS STUDY CONCLUDES THAT EUS-GUIDED GASTROENTEROSTOMY (EUS-GE) SEEMS TO HAVE IMPROVED PATENCY OUTCOMES WHEN COMPARED WITH D-SEMS PLACEMENT FOR PALLIATIVE TREATMENT OF MALIGNANT GASTRIC OUTLET OBSTRUCTION (GOO). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: [DUODENAL SELF-EXPANDABLE METALLIC STENT], BLEEDING - 1 PATIENT, PERFORATION - 3 PATIENTS, PANCREATITIS AND/OR CHOLANGITIS - 4 PATIENTS, SEVERE PAIN - 1 PATIENT, DEATH- 1 PATIENT. [EUS-GUIDED GASTROENTEROSTOMY]: BLEEDING - 21 PATIENTS, PERFORATION - 1 PATIENT, MISDEPLOYMENT - 3 PATIENTS, SEVERE PAIN - 1 PATIENT, DEATH- 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 8 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): GIF-1TH190 (AE). (B)(6): GIF-1TH190 (DEATH). (B)(6): GF-UCT180 (AE). (B)(6): GF-UCT180 (DEATH). (B)(6): PBD-V813W-07 (AE). (B)(6): PBD-V813W-07 (DEATH). (B)(6): B-V232P-A (AE). (B)(6): B-V232P-A (DEATH). THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Description of Event or Problem · 0

    IN THE MEDICAL OPINION OF THE AUTHOR, THE OLYMPUS DEVICE DID NOT CAUSE MALFUNCTION NOR THE ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857692 SINGLE USE 3-LUMEN EXTRACTION BALLOON V SINGLE USE 3-LUMEN EXTRACTION BALLOON FGE AOMORI OLYMPUS CO., LTD. B-V232P-A UNKNOWN(LITERATURE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death NON-OLYMPUS, ELECTROSURGICAL GENERATOR| NON-OLYMPUS, HOT-AXIOS| NON-OLYMPUS, JAGWIRE| NON-OLYMPUS, WALLFLEX DUODENAL| OLYMPUS 7F NASAL-BILIARY DRAINAGE TUBE-V| OLYMPUS, GF-UCT180| OLYMPUS, GIF-1TH190